Stem cell research and related therapies have generated considerable interest in recent years, especially given the potential for these cells to be used to repair or replace other cells damaged by disease or injury. The U.S. Food & Drug Administration (FDA) heavily regulates the marketing of “regenerative medicine products”, including those that use stem cells, by requiring a clinical trial as part of its licensure/approval process.
Effective July 1, 2025, however, the State of Florida passed legislation allowing physicians to use non-FDA approved stem cell therapies for certain treatments or procedures related to orthopedics, wound care, or pain management, provided that the performance of such is within the physician’s scope of practice.
Historically, the FDA has expressed concern about the marketing of unapproved regenerative medicine therapies or products, as well as the adverse effects some patients have experienced as a consequence of these unapproved therapies or products. Despite the FDA’s concerns, Florida’s new law “recognizes the significant potential of stem cell therapies in advancing medical treatments and improving patient outcomes…”. In addition, the law emphasizes the need to ensure that stem cell therapies use ethically sourced stem cells. Specifically, the law prohibits the use of stem cells derived from aborted fetuses or embryos.
Notably, the law’s definition of “stem cell therapies” includes, but is not limited to, human cells, tissues, or cellular or tissue-based products (HCT/Ps). Commonly known as “skin substitute products”, HCT/Ps are designed to facilitate the repair of chronic, hard-to-heal wounds in patients, and are reimbursable by Medicare in certain circumstances. Medicare also reimburses stem cell transplants in limited situations.
In an apparent nod to the FDA’s long-standing concerns about the safety of stem cells and the manner in which they are retrieved, manufactured, stored, and used, the new law requires that the stem cells come from a facility that is:
- registered and regulated by the FDA; and
- certified or accredited by one of four specific organizations.
Further, the law has strict informed consent requirements and mandates explicit disclosures about the nature, character, and anticipated results of the proposed treatment, as well as the fact that the proposed treatment has not been FDA-approved.
It remains to be seen how Florida’s new law will coexist with the FDA’s laws, rules, and regulations as well as Medicare’s coverage criteria and related guidance documents. Similarly, the long-term impact on non-physician providers remains uncertain.
A complete copy of the law is here.
Should you have any questions regarding this new law, please contact the authors, the Garfunkel Wild attorney with whom you regularly work, or contact us at [email protected].
